WASHINGTON — In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.

“Groups from every part of the healthcare supply chain agree that the Proposed Rule raises serious questions about patient safety, cost and access," said Ralph Neas, president and CEO of the Generic Pharmaceutical Association. "That is why pharmacists, chain drug stores, distributors, pharmacy benefit managers, suppliers, healthcare advocacy groups and others are joining us and saying, ‘We can do better,’” he said. “They recognize that by changing the FDA’s long-standing commitment to consistent labeling, this rule could have serious unintended consequences. We are most concerned about the dangerous confusion multiple labels would cause and the increased costs of and reduced access to generic medicines for patients who need them most.”

“Especially noteworthy are the associations representing more than 100,000 pharmacists and more than 40,000 pharmacies who signed on to the letter,” Neas noted. “No one understands better than pharmacists the potential harm this proposed rule could engender. They are the ‘on the ground’ trusted experts who dispense more than three billion generic medicines that Americans use every year. The FDA should listen carefully to their concerns.”

The signatories call for FDA to consider the public health impact of the draft rule. The letter reads: “The FDA and others need to fully explore the potential unintended consequences that the rule may have on patient access and national health care costs. Permitting labeling changes for generic drugs without FDA approval counters 30 years of law requiring generic and brand medicines to have the same labels.”

The letter, addressed to FDA Commissioner Margaret Hamburg, also points out the issue of potential liability for healthcare practitioners, stating: “The Proposed Rule also may expose pharmacists, physicians, generic drug manufacturers and others in the healthcare system to substantial new tort liability costs; these, in turn, would require generic manufacturers to adjust prices to stay in business, withdraw products or decline to launch new affordable versions of brand medicines. This would have a chilling effect on the ability of generic manufacturers and others in the pharmaceutical supply chain to provide affordable medicines to millions of Americans and people across the globe. This is the opposite effect that was intended with the advent of generic medications.”

The letter also pointed to the impact of the Proposed Rule on healthcare system costs, citing a recent study by Matrix Global Advisors. It showed that spending on generic drugs would increase by $4 billion per year (or 5.4% of generic retail prescription drug spending in 2012). Of this, government health programs would pay $1.5 billion, and private health insurance, $2.5 billion.

The letter recognizes the need for a streamlined, efficient process for updating safety information regarding the use of pharmaceutical products for healthcare practitioners and the public, and ends on a positive note, stating, “We believe that simple changes to the proposed rule can achieve all of FDA’s objectives related to efficient communication of important safety information. At this critical juncture, we look forward to working with you and all stakeholders to identify a course of action that does not put patient safety or patient savings at risk.”

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